Build our future together:
Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. In doing so, we are pioneering innovative approaches to science, manufacturing, and commercialization, as well as redefining our understanding of health.
At Regeneron, we use science and innovation to develop life-changing medicines for people with reliable diseases. We are seeking a Manager CMC Regulatory Affairs to join our CMC Regulatory Affairs team. In this role, you will interpret the current, approved, and planned clinical regulatory landscape by contributing to the management of the regulatory submission form process — supporting the review of documentation submitted to global health authorities to enable the release of lots to clinical trials. You will collaborate across cross-functional teams while managing a team of your own,
ensuring submissions appropriately support the release of investigational product. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
When & where:
Hyderabad, India (hybrid)
Discover your role:
Contribute to the management of the regulatory submission form process, which involves reviewing documentation submitted to global health authorities to support the release of lots to clinical trials.
Support cross-functional departments in understanding the current, approved regulatory landscape for all global CTAs.
Participate in cross-functional meetings to help identify CMC regulatory issues related to submission documentation for clinical trials, ensuring timely communication between IOPS and global development.
Participate in the development of procedures and systems for enhanced tracking of global regulatory submission packages and appro